Union government will now need to tweak the existing Drugs & Cosmetic Rules to permit online pharmacy business model. These include issuing a separate norms for sale of medicines on the internet, indicate suitable punishment clauses for any violations and mandate a 48-hour validity period for prescriptions, said Dr. BR Jagashetty, former national adviser (drugs control) to Union health ministry and former Karnataka Drugs Controller.

As per the current D&C Rules, it is not possible to upload the required medicines especially prescription drugs on any website directly from a customer and then dispense them. However, these existing rules are sufficient for ethical online sales of medicines with a few provisions related to delivery of medicines which can be covered in the recently announced guidelines by CDSCO on Good Distribution Practices, he said.

Further, the government will need to define the over-the-counter (OTC) drugs whose sale can be done without prescription and no supervision of pharmacist. This will enable sales of these medicines online.

Online sale of medicines can be recognized under D&C Act if the same is incorporated under Section 18 which is the main clause for prohibition of sale of various categories of drugs. This will help in fixing punishment clauses. The online pharmacy websites should have retail license from respective State Licensing Authority and then they should get registered with CDSCO for which hefty fees can be fixed.

The pre-requisites to seek licenses should be minimum 10 years marketing experience in the pharmaceutical distribution with disclosure of turnover of the last three years.

Adherence to Rule 65 (11) (c) of D&C Rules which refers to endorsement of the prescription for having dispensed should be mandated and severe punishment for its violation.

At present the ground reality is that in most of bigger cities pharmacists are not found to be present at retail outlet during business hours which is reported to be 25-30 per cent or more in certain locations.

Another issue is the paucity of inspectors. The ideal situation will be for every 250-300 sales outlets one drug inspector is needed. Every 30-40 manufacturing units can be manned by one drug inspector.

Government analyst should be able to give the analysis report within 15 days except for animal test, microbiology or sterility test where it can be given within 45 days otherwise the purpose will not serve since the sale is not prohibited after drawing drug / cosmetic/ device for test, he said.

Rule 65(10) mentions about the prescription’s model which should be in writing, with his signature and date. Section 4 of IT Act 2008 acknowledges the need for both hand written and electronic format but not scanned or photocopy. Similarly Section 5 of IT Act 2008 appreciates signature to be either by hand or as digital signature of prescriber.

Home deliveries of medicines must be undertaken only by registered pharmacists recognized under D&C Rules by assigning a designation on similar lines like registered pharmacist (RP) for retail business, competent person (CP) for wholesale business, competent technical staff (CTS) for manufacturing and testing business.

Prescription audit provision has to be made under D&C Act / Rules with suitable punishment clauses for any violations. This audit is required for verifying even rationality of prescribing various medicines or diagnosis by the prescriber as it involves lot expenditure to the patient.

Therefore stringent penalties for Internet crimes for sale of unsafe drugs and devices are mandated. CDSCO must ensure a section on its website on the ‘authenticity of online pharmacies’, said Dr. Jagashetty.